DIN EN 13641:2002-08
Current
The latest, up-to-date edition.
ELIMINATION OR REDUCTION OF RISK OF INFECTION RELATED TO IN VITRO DIAGNOSTIC REAGENTS
Hardcopy , PDF
German
01-01-2002
Important note : Users cannot be edited or removed once added to your Multi user PDF.
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Requirements related to design and manufacture
5 Information supplied by the manufacturer
Annex ZA (informative) Clauses of this European Standard
addressing essential requirements or other
provisions of EU Directives
Bibliography
This standard is included in DIN Handbook 378. Defines requirements related to design and manufacture in order to effectively control the risk of infection caused by in vitro diagnostic reagents including reagent products, calibrators, control materials and kits, hereinafter called IVD reagents. It applies to in vitro diagnostic reagents containing material of human origin.
| DocumentType |
Standard
|
| Pages |
12
|
| PublisherName |
German Institute for Standardisation (Deutsches Institut für Normung)
|
| Status |
Current
|
| Standards | Relationship |
| NF EN 13641 : 2002 | Identical |
| NBN EN 13641 : 2002 | Identical |
| NEN EN 13641 : 2002 | Identical |
| NS EN 13641 : 1ED 2002 | Identical |
| I.S. EN 13641:2002 | Identical |
| UNE-EN 13641:2002 | Identical |
| SN EN 13641 : 2002 | Identical |
| UNI EN 13641 : 2003 | Identical |
| BS EN 13641:2002 | Identical |
| EN 13641:2002 | Identical |
Access your standards online with a subscription
Features
-
Simple online access to standards, technical information and regulations.
-
Critical updates of standards and customisable alerts and notifications.
-
Multi-user online standards collection: secure, flexible and cost effective.